Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes

Phase 1

Recruiting

• Conditions: Type 1 Diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-509217-37-00
• Lead Sponsor: Katholisches Klinikum Bochum gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Diabetes mellitus type 1, HbA1c = 6.0% [42 mmol/l] and = 8.0% [64 mmol/l], Generally good overall health, Age = 18 and = 80 years, Body mass index (BMI) = 18.5 and = 35 kg/m²

Exclusion Criteria

Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus, Blood donation within the past 12 weeks prior to the study, Pregnancy, Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment, Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day), Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer), Participation in other medical studies within the past three months, Inability to provide informed consent, Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs), Conventional insulin therapy, Proliferative retinopathy, Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l]), Allergies or intolerances that could hinder the study's execution, Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization, Positive medical history of gastrointestinal diseases, especially symptomatic upper or lower gastrointestinal tract disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease, pancreatitis, gastric conditions like gastroparesis), History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy), Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite, Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula), Chronic liver disease (transaminases > 2 times the upper normal limit), Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified